UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison between new laser endscopic imaging and histological imaging in gastric cancer
Title of the study (Brief title)	Comparison between new laser endscopic imaging and histological imaging in gastric cancer
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare magnifying endoscopy with Blue Laser Imaging (ME-BLI) endoscopic image and histrogical findings of endoscopic submucosal dissection (ESD) specimen using the cases that were carried out ESD for the early gastric cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the diagnostic performance of demarcation line of cancer and non-cancerous part from the comparison of ME- BLI image and histopathological image.
Key secondary outcomes	To consider the differences in the findings of ME-BLI and ME-NBI histopathologically.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases with early gastric cancer that underwent ESD at the Hospital of Kyoto Prefectural University of Medicine thereafter January 2011. In this cases that have enough ME-BLI images and histopathological images.
Key exclusion criteria	Cases that not underwent ME-BLI. Cases that underwent ME-BLI but with inadequate images.
Target sample size	30

Research contact person
Name of lead principal investigator	Yuji Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	465,Kajii-cho,Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	+81-75-251-5519
Email	ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person	Osamu Dohi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	465,Kajii-cho,Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	+81-75-251-5519
Homepage URL
Email	osamu-d@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 09 Month 01 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	The aim of this study is to evaluate between BLI and histological findings compared with NBI findings.

Management information
Registered date	2016 Year 09 Month 14 Day
Last modified on	2017 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027516